Quality Engineer

W. L. Gore & Associates; Phoenix (AZ); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Associate Stock Ownership Plan

Profit-sharing

Job summary

W. L. Gore & Associates seeks an experienced Quality Engineer in Phoenix to support manufacturing quality and regulatory compliance for implantable device products.

You will help update quality systems, perform product quality determinations, and solve problems with cross-functional teams. The role emphasizes risk-based decision making, CAPA development, and mentorship to ensure product release quality while aligning with ISO 13485 and FDA expectations.

Qualifications

• Bachelor’s degree in engineering or science required with 3+ years hands-on experience.
• Structured problem-solving using 8D, 8‑Step, DMAIC or PDCA with root-cause methods.
• Knowledge of risk management methods and product risk assessment.
• Apply engineering fundamentals and statistics to quality support and troubleshooting.
• Ability to manage multiple projects with teams and timelines.
• Ability to mentor others and work in cross‑functional teams.
• Capable of identifying critical issues and guiding risk‑based decisions.
• Strong documentation and communication of technical work.
• Travel up to 5% must be possible.

Responsibilities

• Ensure ISO and global quality standards for design and performance.
• Update quality system documentation and CAPA planning.
• Support product quality determinations and nonconformance investigations.
• Apply statistics to sampling plans and data-driven decisions.
• Collaborate with manufacturing, QA, and regulatory in product release.
• Maintain Design History Files and risk management tools.
• Provide mentorship and technical support across teams.
• Drive root cause analysis and corrective actions for defects.
• Develop deep product knowledge to support audits and changes.
• Improve processes with cross-functional project participation.

Skills

Structured problem-solving

Statistical analysis

Risk management

Project management

Team collaboration

Education

Bachelor’s Degree in Engineering or Science

Job description

About the Role

We are looking for an experienced Quality Engineer to join our team. In this role, you will utilize your skills as a member of a diverse team in providing technical support of commercialized product manufacturing. Your daily activities may include updating quality system documentation, aiding in product quality determinations, hands‑on problem solving, and ensuring operator safety. You will be a part of cross‑functional teams that ensure continued compliance with ISO and other global quality standards/guidelines that are applicable to implantable medical devices.

This role will be located at one of our facilities in Phoenix, Arizona with the possibility of a hybrid work arrangement.

Responsibilities

• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results
• Ensure continued compliance to ISO and other global quality standards/ guidelines for product design and performance, addressing documentation gaps and updates (including documents such as FMEAs, ERT, PERC, etc)
• Identify and address opportunities to continuously improve our manufacturing processes and assess opportunities for regulatory, quality, ergonomic, safety, environmental, and cost impact
• Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement
• Partner with other engineers in a wide range of process projects throughout the development cycles: scale‑up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
• Provide support and mentorship utilizing engineering principles and historical/materials/clinical/mechanical knowledge to ensure quality decisions are made related to product release, and supplier quality
• Provide technical support for the manufacturing of the GORE PRECLUDE Pericardial Membrane and GORE-TEX Cardiovascular Patch in addition to collaborating with other functions such as Quality Assurance, Manufacturing, and Regulatory in execution of work
• Apply formal problem‑solving techniques to determine root cause in troubleshooting product non‑conformances and developing and implementing corrective and preventative action (CAPA) plans
• Ensure design requirements are met by owning quality engineering design control deliverables and maintaining product Design History Files (i.e., Design input/output documentation, Risk management tools)
• Develop deep technical and historical knowledge of the product/product documentation to support quality processes (audit, change control) and drive the discovery of root causes in non‑conformance and CAPAs

Required Qualifications

• Bachelor’s Degree in Engineering or Science with minimum 3 years of hands‑on engineering work experience
• Experience applying structured problem‑solving approach (such as 8D, 8‑Step, DMAIC or PDCA) that drives root cause analysis using 5‑Why, Why Trees, and Fishbone analysis
• Knowledge in Product Risk Management (Risk identification, analysis, and mitigation methods)
• Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
• Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
• Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects to completion
• Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk‑based decision making
• Ability to document, communicate, and present technical bodies of work
• Ability to travel up to 5%

Desired Qualifications

• Minimum 3 years of relevant engineering experience in the Medical Device Industry
• Experience with applicable regulatory standards and quality system expectations (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971)

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well‑being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit‑sharing”. Learn more at gore.com/careers/benefits
Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug‑free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.